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Notice

Prospective Grant of Exclusive License: Prevention, Prophylaxis, Cure, Amelioration, and/or Treatment of Infection and/or the Effects Thereof of Chikungunya Infections in Humans

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in Patent Applications USSN 61/118,206, filed on November 26, 2008, and 61/201,118, filed on December 5, 2008; and PCT/US2009/006294, filed November 24, 2009; entitled “Virus Like Particle Compositions and Methods of Use”, to Merck Sharp & Dohme Corp. having a place of business in 770 Sumneytown Pike, West Point, PA 19486. The patent rights in this invention have been assigned to the United States of America.

DATES:

Only written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before October 25, 2010 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Cristina Thalhammer-Reyero, PhD , M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail: ThalhamC@mail.nih.gov; Telephone: 301-435-4507; Facsimile: 301-402-0220.

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SUPPLEMENTARY INFORMATION:

The prospective worldwide exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 30 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The invention relates to compositions and methods of use as vaccines of virus-like particles (VLPs) expressing one or more alphavirus capsid or envelope proteins, and in particular Chikungunya Start Printed Page 58416virus (CHIKV) envelope proteins. The invention also describes DNA, viral or other gene-based vector and VLP vaccines, methods of making and methods of their use in inducing immunity to alphavirus infection. Alphaviruses are RNA-containing viruses that cause a wide variety of mosquito-transmitted diseases, including equine encephalitis. CHIKV, an alphavirus in the family Togaviridae, was first isolated in Tanzania in 1952 and is transmitted to humans by mosquitoes. The disease caused by CHIKV resembles infection by dengue virus, characterized by rash, high fever, and severe, sometimes persistent arthritis.

The field of use may be limited to “Prevention, prophylaxis, cure, amelioration, and/or treatment of infection and/or the effects thereof of Chikungunya infections in humans”.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

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Dated: September 20, 2010.

Richard U. Rodriguez,

Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 2010-23975 Filed 9-23-10; 8:45 am]

BILLING CODE 4140-01-P